UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010786 |
|---|---|
| Receipt number | R000012622 |
| Scientific Title | A prospective study of esomeprazole treatment for ulcer healing after gastric endoscopic submucosal dissection |
| Date of disclosure of the study information | 2013/05/27 |
| Last modified on | 2017/10/24 08:42:18 |
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Basic information
Public title
A prospective study of esomeprazole treatment for ulcer healing after gastric endoscopic submucosal dissection
Acronym
Effect of esomeprazole for post ESD ulcers
Scientific Title
A prospective study of esomeprazole treatment for ulcer healing after gastric endoscopic submucosal dissection
Scientific Title:Acronym
Effect of esomeprazole for post ESD ulcers
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the healing rates of post-ESD ulcers in response to the 2-week or 4-week esomeprazole treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the healing rates of post-ESD ulcers 29 days after ESD
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 20mg/day esomeprazole for 2 weeks and 300mg/day rebamipide for 8 weeks
Interventions/Control_2
Administration of 20mg/day esomeprazole for 4 weeks and 300mg/day rebamipide for 8 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who will undergo ESD for early gastric cancer
Key exclusion criteria
age below 20, active gastric or duodenal ulcers, hypersensitivity to esomeprazole or rebamipide, severe heart disease, severe renal dysfunction, severe liver dysfunction, expectant mothers, patients taking NSAIDs, anticoaglant or antiplatelet drugs and so on
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunari Nakamoto |
Organization
University of Fukui Hospital
Division name
Department of Gastroenterology
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan 910-1193
TEL
0776-61-8351
nakamoto-med2@med.u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Suto |
Organization
University of Fukui Hospital
Division name
Department of Gastroenterology
Zip code
Address
23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui, Japan 910-1193
TEL
0776-61-8351
Homepage URL
hrykstu@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui Hospital
Institute
Department
Personal name
Funding Source
Organization
Second department of Internal Medicine, University of Fukui
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 23 | Day |
Last modified on
| 2017 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012622
